IceCure(ICCM) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the same period of 2024, primarily due to a lack of revenue from Terumo, the distributor in Japan [16] - Gross profit for the same period was $626,000, down from $1,034,000 in the prior year, resulting in a gross margin of 30% compared to 43% in 2024 [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 per share in the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024, with a cash balance of $11.8 million as of October 31, 2025 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other Asian territories, and North America, partially offset by an increase in Latin America [16] - The company expects fluctuations in quarterly revenue as commercial activities ramp up following the FDA's marketing clearance for ProSense [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, targeting a population of approximately 200,000 patients annually in the U.S. [6][8] - The ProSense system is expected to benefit from a CPT-3 code covering approximately $3,800 in facility costs, which is anticipated to increase to just over $4,000 in early January 2026 [10] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. and globally, with plans for a post-market study involving 30 clinical sites [9][10] - IceCure aims to drive growth by expanding clinical evidence, improving reimbursement, and entering new markets, particularly in Brazil and Japan [12][15] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has significantly changed the company's growth trajectory and is optimistic about the future [27] - The company is entering an exciting growth phase, with expectations for increased adoption of ProSense in both clinical and commercial settings [15] Other Important Information - The company has received regulatory approval for its next-generation cryoablation system in Israel and secured a notice of patent allowance for its cryo probe in the U.S. and Japan [12][14] - IceCure is experiencing high global interest from clinicians following the FDA decision, with plans for participation in upcoming medical conferences [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in communication to finalize it, with expectations for approval by early next year [20][21] Question: Clarification on the addressable patient population - Management elaborated that the addressable market includes approximately 46,000 low-risk patients over 70, 88,000 patients not eligible for surgery, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]